This invention relates to body fluid delivery systems and more particularly to an autotransfusion system which is integrally incorporated for easy use during an operative procedure.
The prior art contains many examples of autotransfusion systems which generally operate as follows.
An autotransfusion system essentially is a self-contained disposable system for intra-operative collection, anticoagulation, filtration and reinfusion of blood shed into body cavities. The system employs a special suction wand which incorporates a citrate-phosphate-dextrose (CPD) anticoagulant metering system. The system is used to collect blood which flows into a blood reservoir or cardiotomy reservoir. The blood reservoir may be connected to a blood bag which is used to deliver the blood to the patient via an extension set which contains a microemboli filter, while simultaneously permitting continued blood collection in the blood reservoir.
Such systems have been employed in many situations and have been found to be completely effective and essentially an important part of certain surgical procedures. For example, the system is used where the patient experiences rapid blood loss, where there is an unavailability of appropriate bank blood or in surgery in which the complications of bank blood must be avoided. The systems can be further employed in conjunction with cell washing autotransfusion devices or where the patient's religious convictions precludes the use of bank blood.
As indicated, such systems have been described extensively in the prior art. See, for example, the following U.S. Patents.
U.S. Pat. No. 4,547,186 issued to R. H. Bartlett entitled "Autotransfusion System" and dated Oct. 15, 1985. This patent describes a system for autotransfusion where the surgeon uses an aspirating wand or tube coupled to a vacuum source through a reservoir for receiving aspirated blood. From that reservoir blood flows to a receiving bag in a relatively low position below the elevation of the patient. When there is sufficient blood supply in the bag the bag is elevated from its lower position to a point higher than the patient. Blood then flows from the elevated bag, by gravity or externally applied pressure, through a conducting tube and a needle into the patient. When the bag is then substantially emptied, it is again lowered to an elevation lower than the blood reservoir for repetition of the operation. If desired, an anticoagulant can be introduced into the aspirated blood. As one can ascertain from the above-noted patent, the system is described and comprises a multiplicity of connecting tubes and various other devices which are associated with an IV pole which supports the system.
U.S. Pat. No. 4,540,406 issued on Sept. 10, 1985 to C. Miles and entitled "Anticoagulant Delivery System For Use With An Autotransfusion System". In that patent, anticoagulant is added to blood being aspirated through a hand-held wand having an venturi throat. The anticoagulant flows into the wand from a generally closed anticoagulant reservoir, which is higher than the wand, as replacement air flows into the anticoagulant air reservoir. This allows air inflow to be controlled by a regulator which is fixed on the wand and in accordance with the amount of aspirated blood flowing in through the venturi throat. The patent also shows an autotransfusion system of the type that this present invention is concerned with.
U.S. Pat. No. 4,551,131 issued on Nov. 5, 1985 to C. Miles and entitled "Autotransfusion System With Anticoagulant Delivery System". That patent shows a movable aspiration wand which carries a tank for anticoagulant which is replenished from an anticoagulant source fixed at a high elevation and is connected to a blood reservoir at a low elevation. Differences in wand height relative to the source and to the blood reservoir are compensated for so that differences in wand height and corresponding blood and anticoagulant height do not substantially vary the anticoagulant portion added to the aspirated blood. In any event, schematics and drawings concerning that system are also shown.
As one can ascertain from the above-noted references autotransfusion systems have been employed in the prior art. As one will also ascertain, such systems are relatively complex and require a great deal of set up time in order to utilize the systems. Based on the nature of such systems, the individual components are bulky, such as the blood reservoir and other components. These components, as one can ascertain from the above prior art, have to be coupled together via various tubes and other devices so that the system maintains an operable position. Such set up procedures are extremely prolonged and instruction manuals for operating and setting up such systems are extensive.
In any event, the prior art has experienced a great deal of difficulty in utilizing such systems due to the difficulties in connecting such systems together.
In this respect, it is an object of the present invention to provide an autotransfusion system which, due to the nature of its packaging, will enable one to utilize the system components in a simple and reliable manner. The particular packaging and utilization of an autotransfusion system, according to the teachings of this invention, saves a great deal of expensive labor time and, further, fully assures that the system is set up in a proper and reliable manner, and that sterility of system components is assured throughout the unpacking, set-up and utilization procedures.
The technique for packaging such a system further insures that various heights, levels and so on are automatically maintained and provides a simple means for allowing an unskilled laborer to set a system up prior to an operative procedure. The packaging, as described, serves as an integral part of the system and is adapted to be mounted directly on an intravenous (IV) pole. By means of the packaging, which includes a procedure chart, a relatively inexperienced practitioner can set up the system in a simple and reliable manner. It is further noted that the packaging also allows for the easy transportation of such systems. For example, from a source of distribution to hospitals and various other facilities which employ such systems in the ordinary course of business.